SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Connecting Your Project to the Right Service Provider
BioDuro’s Vice President of Formulation, Hong Li, PhD, was recently featured in Drug Development & Delivery as part of its special feature exploring how pharmaceutical companies are connecting development programs with the right formulation and manufacturing partners.
In the feature, Dr. Li discusses BioDuro’s integrated approach to formulation development and manufacturing, with a particular focus on overcoming the complex challenges associated with oral peptide delivery.
BioDuro: Transforming Complex Oral Peptide Delivery Challenges Into Clinically Viable Assets
BioDuro offers integrated formulation development and cGMP manufacturing services spanning pre-formulation through clinical supply manufacturing. Its capabilities begin with systematic pre-formulation characterization, leveraging scientific experience to evaluate physicochemical properties, identify drug delivery challenges early, and support informed candidate selection.
BioDuro’s integrated DS-DP-DMPK model enables seamless collaboration across discovery, development, and manufacturing functions, explains Hong Li, PhD, Vice President, Formulation, BioDuro.
“This integrated approach supports IND-ready formulations in as little as 8–12 weeks, helping accelerate development timelines,” says Dr. Li. “In particular, our solubility enhancement platform addresses challenges associated with poorly soluble compounds and has demonstrated strong success in improving oral bioavailability.”
Oral peptide formulation services are seeing increased customer demand, driven largely by growing interest in GLP-1 therapeutics and the broader peptide pipeline. BioDuro has developed tailored formulation strategies based on the specific physicochemical and biopharmaceutical characteristics of each peptide candidate. Oral peptide delivery remains highly challenging due to poor gastrointestinal stability, rapid enzymatic degradation, and limited intestinal permeability, all of which contribute to extremely low oral bioavailability.
One BioDuro program involved the development of an oral GLP-1 formulation. Although the peptide demonstrated excellent aqueous solubility, intestinal permeability was negligible, explains Dr. Li. BioDuro designed a novel oral formulation utilizing a proprietary permeation enhancer and implemented a systematic development workflow spanning peptide characterization, preformulation assessment, and in vitro/in vivo proof-of-concept studies.
The program progressed successfully through IND submission and GMP manufacturing, generating positive Phase I clinical results and ultimately supporting a significant out-licensing transaction for the client, says Dr. Li. The candidate has since advanced into Phase II clinical studies.
Hong Li’s perspective was originally published as part of the Drug Development & Delivery special feature, “Outsourcing Formulation Development & Manufacturing: Connecting Your Project to the Right Service Provider.”
